WEEK ENDING JULY 14

The Food and Drug Administration announces the nationwide recall of SangCya oral solution, a generic version of the anti-rejection drug cyclosporine (Neoral oral solution), because of clinical evidence that the generic drug's availability is reduced relative to Neoral oral solution if the drug is administered with apple juice. Patients taking cyclosporine capsules are not affected by this recall.

WEEK ENDING JULY 21

PRODUCT Tricana(tm) Capsules, 1 mg, in units of 90, Rx for the treatment of obesity and reducing the problem areas of fat.
CODE All lot codes.
MANUFACTURER Thermo-Life International, San Carlos, California.
DISTRIBUTION Nationwide.
QUANTITY 33,203 bottles were distributed.
REASON Unapproved new drug.

PRODUCT Glyburide Tablets, USP, (micronized), 6 mg, in 100-tablet bottles, Rx indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type II) whose hyperglycemia cannot be satisfactorily controlled alone.
CODE Lot #ST2343A EXP 9/00.
MANUFACTURER MOVA Pharmaceuticals Corporation, Caguas, Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY 8,407 bottles were distributed.
REASON Blend uniformity failure.

PRODUCT Leucovorin Calcium Injection, USP, 100 mg (10mg/mL), in 10 mL single dose flip top vial.
CODE Lot #59-387.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY Cardinal Distribution, Hudson, Wisconsin (responsible firm)
DISTRIBUTION Minnesota, South Dakota, Iowa.
QUANTITY 156 vials were distributed.
REASON Product was not stored as labeled-under refrigeration-by distributor (recalling firm).

PRODUCT Alcohol Prep Antiseptic Pad in Lovenox(r) ContinuCare(tm) Program AT HOME KITS.
CODE All lot numbers.
MANUFACTURER Aventis Pharmaceutical Products, Collegeville, Pennsylvania.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Canada, Brazil, France, United Kingdom, Puerto Rico.
QUANTITY Firm estimated that 300 kits remained on market at time of recall initiation.
REASON Lack of assurance of sterility for the Clinipad Corporation manufactured alcohol prep pads.

PRODUCT Meperidine HCl Injection, USP, 75 mg/mL, 1 mL fill in 2 mL tubex(r), Rx.
CODE Lot #2001276 EXP 1/02.
MANUFACTURER Wyeth Ayerst Laboratories, West Chester, Pennsylvania.
DISTRIBUTION Tennessee.
QUANTITY 343,124 units were distributed.
REASON Lack of assurance of sterility.

PRODUCT Humegon(r) Vial lyophilized powder (memotropins for injection, USP), 2 mL vial, 75 IU, Rx infertility drug.
CODE Lot Numbers: 0990199300, 1000299300, 10103993000, 1020499300, 103599300, 1040699300, and 1050799300.
MANUFACTURER Organon, Inc., West Orange, New Jersey.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Lot # Amount Shipped
0990199300 16,796 units
1000299300 16,524 units
1010399300 16,220 units
1020499300 16,661 units
1030599300 16,638 units
1040699300 16,827 units
1050799300 11,276 units.
Note: Each unit consists of five Humegon vials and five 2 mL Sodium Chloride Injection, USP vials.
REASON Potency failure (fish component) at stability testing - 30 degrees C).

PRODUCT Lanoxin Tablets, 0.125 mg, in bottles of 30 and 100, Rx oral cardiotonic indicated for the treatment of mild to moderate heart failure and for the control of ventricular response rate in patients with chronic atrial fibrillation.
CODE Lot Numbers: 9355140, 0006075, and 9354174.
MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina.
RECALLED BY Allscripts, Inc., Libertyville, Illinois
DISTRIBUTION California, Illinois, Iowa, Wisconsin, Pennsylvania, Arizona, Indiana, Louisiana, Florida, Idaho, Michigan, Hawaii, Maine.
QUANTITY 86 bottles of 30 and 19 bottles of 100 tablets were distributed; firm estimated that 30 percent of the product remained on market at time of recall initiation.
REASON Tablets do not meet thickness specification and therefore may be subpotent.

PRODUCT Atropisol(r) Atropine Sulfate) Ophthalmic Solution 1%, 1 mL, Rx indicated for the treatment of inflammatory conditions of the iris or uveal tract and also as a cyclopegic or mydriatic for refraction.
CODE Lot Numbers and EXP dates: W102 4/00, W103 4/00, W104 5/00, W105 5/00, W106 8/00, X2091 2/00, X2092 3/01, X2093 8/01, X2094 8/01, X2095 8/01, X2096 9/01, X2097 9/01 X2098 9/01 X2099 9/01.
MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico (finished product).
RECALLED BY CIBA Vision Corporation, San German, Puerto Rico
DISTRIBUTION Nationwide.
QUANTITY 14,665 units were distributed; firm estimated that 3,300 units remained on market at time of recall initiation.
REASON Product labeled with incorrect expiration date.

PRODUCT Vasosulf(r) Ophthalmic Solution (sulfacetamide sodium 15%-Phenylephrine
Hydrochloride 0.125%), Rx indicated for the treatment of conjunctivitis, corneal ulcer, and other superficial ocular infections due to susceptible microorganisms, and an adjunctive in systemic sulfonamide therapy of trachoma. NDC # 58768-883-05 (5 mL); NDC #58768-883-15 (15 mL).
CODE X1095 EXP 1/01, Y1104 EXP 7/00, X1105 EXP 2/01.
MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico (finished product).
RECALLED BY CIBA Vision Corporation, San German, Puerto Rico
DISTRIBUTION Nationwide.
QUANTITY 19,872 units were distributed; firm estimated that 9,300 units remained on market at time of recall initiation.
REASON Failure to revalidate new manufacturing specifications.

PRODUCT Triazolam Tablets, USP, 0.125 mg and 0.25 mg, Rx product taken orally as sleeping aid, under the following labels: Par NDC: 49884-453-62 (10x10), 0.125 mg Tablets 49884-453-05 (500), 0.125 mg Tablets Par NDC: 49884-454-62 (10x10), 0.25 mg Tablets 49884-454-05 (500), 0.25 mg Tablets Qualitest NDC: 0603-6186-10 (10x10), 0.125 mg Tablets Qualitest NDC: 0603-6187-10 (10x10), 0.25 mg Tablets.
CODE 0.125 mg Tablets:
Mfr. Lot#     Par Lot#     Control#     Size     EXP         Label
TE030             013635         014152     10x10     5/2000     Par
                                             014153     10x10     5/2000     Qualitest
                                             014154     500s       5/2000     Par
                                             015617     10x10     5/2000     Par
9B126             017499         017587     500s       2/2001     Par
                                             017589     10x10     2/2001     Par
                                             017590     10x10     2/2001     Par
                                             017591     10x10     2/2001     Par
0.25 mg Tablets:
TF064             013730         013871     10x10     6/2000     Par
                                             013872     10x10     6/2000     Qualitest
                                             013874     500s       6/2000     Par
9F200             018698         019113      500s       6/2001     Par.
MANUFACTURER Alphapharm Pty Ltd., Carole Park, Old, Australia (bulk tablets).
RECALLED BY Par Pharmaceutical, Inc., Spring Valley, New York
DISTRIBUTION Nationwide.
QUANTITY 0.125 mg: 10x10s total shipped: 4689 units 500s total shipped : 2661 units
0.25 mg:10x10s total shipped: 6961 units 500s total shipped : 1385 units.
REASON Individual impurity specification failure.

PRODUCT a) Rubratope(r)-57 Diagnostic Kit (Cyanocobalamin Co 57), Rx, 4 capsules (NDC #0270-3868-10); b) Rubratope(r) Cyanocobalamin Co 57 Capsules, UPS, Rx, 5 and 10 capsules, intended for the diagnosis of pernicious anemia and as a diagnostic adjunct in other defects of intestinal vitamin B12 absorption.
CODE Lot Numbers and EXP dates: UW408681 10/1/99, UW308661 10/1/99, UW308662 10/1/99, UX408681 10/20/99, UX308661 10/20/99, UX308662 10/20/99, UZ408681 1/6/00, UZ408661 1/6/00, UZ408662 1/6/00, WA408681 1/22/00, WA408661 1/22/00, WA418661 1/22/00, WA408662 1/22/00, WD408681 6/5/00, WD418681 6/5/00, WD408661 6/5/00, WD408662 6/5/00, WD508662 6/5/00, WE108681 5/12/00, WE408661 5/12/00, WE308662 5/12/00, WE408662 5/12/00, WG408681 6/19/00, WG408661 6/19/00, WG408662 6/19/00.
MANUFACTURER Bristol-Myers Squibb Company, New Brunswick, New Jersey.
RECALLED BY Bracco Diagnostics, Inc., Princeton, New Jersey (responsible firm)
DISTRIBUTION Nationwide.
QUANTITY 10 kits, 10 bottles of 5 capsules, and 20 bottles of 10 capsules were distributed.
REASON Incorrect capsule release assay which could lead to a false negative calculation.

PRODUCT MediGel H (Topical Hydrocortisone Hydrogel), 1% Hydrocortisone, in 4-ounce plastic bottles, OTC. NDC #57437-7777-04.
CODE Lot No. LMQ.
MANUFACTURER Henley Healthcare, Inc., Sugarland, Texas.
DISTRIBUTION Nationwide.
QUANTITY 228 bottles were distributed.
REASON Super-potent.

PRODUCT Vicoprofen(r) Tablets (hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg), in 500-count bottles, Rx. NDC #0044-723-03.
CODE Lot #0000060685 EXP 10/01.
MANUFACTURER Knoll Pharmaceutical Company, Whippahy, New Jersey.
RECALLED BY Knoll Pharmaceutical Company, Mt. Olive, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 3,475 bottles were distributed.
REASON Misbranded - Some bottles have partially illegible lot numbers and/or expiration dates.

PRODUCT IBU(r) Tablets (Ibuprofen), 800 mg, in 500-count bottles, Rx non-steroidal anti-inflammatory agent. Par NDC #49884-469-05.
CODE Lot #20692 EXP 11/00.
MANUFACTURER BASF Corporation, Shreveport, Louisiana.
DISTRIBUTION Nationwide.
QUANTITY 9,279 bottles were distributed.
REASON Product exceeds impurity specification at 18-month stability (4-isobutylacetophenone).

PRODUCT Aspirin Tablets, 325 mg, in units of 2, 100, and 300, Rx under the following labels: Pharmacist Formula (2 tablets); Albertson (100 count); and Target (300 count).
CODE Lot #8M00476 EXP 10/01.
MANUFACTURER Leiner Health Products, Inc., Kalamazoo, Michigan.
RECALLED BY Leiner Health Products, Inc., Carson, California
DISTRIBUTION California, Florida, Idaho, Hawaii, Illinois, Maryland, Minnesota, Texas, Virginia.
QUANTITY 47,832 10-tablet bottles; 9,276 300-count bottles and 5,424 boxes 100 tablet blisters were distributed.
REASON Dissolution failure (24 month stability).

WEEK ENDING JULY 28

PRODUCT JPI Jones Daniels Pharmaceuticals Levoxyl (Levothyroxine Sodium Tablets), 75 mcg (0.075 mg), Rx, packaged in unit-dose strips 10/10-tablet strips per box.
CODE Lot #6221 EXP 02/01.
MANUFACTURER Daniels Pharmaceuticals, St. Petersburg, Florida.
RECALLED BY Jones Pharma, Inc., St. Louis, Missouri
DISTRIBUTION Nationwide.
QUANTITY 440 10/10-tablet strip boxes were distributed.
REASON Mislabeling - The milligram conversion on the unit blisters is incorrectly declared as 0.75 mg.

PRODUCT Sodium Edecrin(r) Intravenous (Ethacrynate sodium), 50 mg, single dose vial, Rx indicated for the treatment of edema.
CODE Lot Numbers: 1398J EXP 6/01, 0564K EXP 8/01, 0462K EXP 9/01.
MANUFACTURER Merck and Company, West Point, Pennsylvania.
DISTRIBUTION Nationwide, Germany, and Israel.
QUANTITY 16,712 units were distributed.
REASON pH failure (six month stability).